At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Azathioprine 50Mg Tab +1 moredrug
Likely dose
Azathioprine 50Mg Tabfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Centre, Two Period Crossover Study to Assess the Bioequivalence of an Oral Azathioprine Suspension 10 mg/mL (Jayempi™) Versus Oral Azathioprine Tablet 50mg (Imurek®) in at Least 30 Healthy Adult Subjects Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Azathioprine 50Mg Tab and Azathioprine 10mg/mL oral suspension for Therapeutic Equivalency. Completed, enrolled 30 participants across 2 sites.
Detailed Summary
A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland.) in at least 30 healthy adult subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTherapeutic Equivalency
CountriesUnited Kingdom
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
First PostedApr 2019
Primary CompletionMay 2019
Study CompletionMay 2019
TodayJul 2026
First PostedApr 29, 2019
Enrollment StartApr 11, 2019
Primary CompletionMay 24, 2019
Study CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.2 years ago
Interventions
Azathioprine 50Mg Tabdrug
tablet
Azathioprine 10mg/mL oral suspensiondrug
oral suspension